Failure Analysis of Patellofemoral Arthroplasty

Sponsor
Anders Odgaard (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04772625
Collaborator
Stryker Orthopaedics (Industry)
550
1
39
14.1

Study Details

Study Description

Brief Summary

The purpose of the retrospective cohort study is 1) to determine preoperative risk factors for revision af patellofemoral arthroplasty, and 2) to provide a detailed description of indications for revision after patellofemoral arthroplasty. All patients operated with patellofemoral arthroplasty in Denmark from January 1, 2008 to December 31, 2015, will be included in the cohort.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Patellofemoral arthroplasty

Detailed Description

Approx. 11,000 operations with the insertion of a knee arthroplasty (knee prosthesis) are performed annually DK. The durability and quality of the treatment are assessed with prosthesis survival, that expresses the proportion of prostheses that are still functional after a given number of years (eg the 10-year prosthesis survival for all types of knee prostheses in DK is approximately 94%).

Unicompartmental implants are increasingly used, so that only the worn part of the knee is replaced. Especially for osteoarthritis between the patella and the femur, a patellofemoral prosthesis (PFA - patellofemoral alloplasty) can be inserted, which is much smaller than the traditional full prosthesis (TKA - total knee arthroplasty).

PFA operations are controversial. A recently published Danish study (double-blind RCT) comparing TKA and PFA has shown that PFA patients achieve greater satisfaction, better knee function and greater quality of life than TKA patients. A recent study has also demonstrated that the cost of a PFA procedure is less than that of a TKA. As a paradox to this clear RCT finding, all national implant registers (Sweden, England, New Zealand, Denmark, etc.) show a significantly poorer prosthesis survival for PFA compared with TKA.

It is important for the future treatment of patients with severe osteoarthritis between the patella and femur to understand the cause of the discrepancy between RCT and registry results. The discrepancy gives rise to a number of questions regarding. indications, techniques, competences, postoperative regimens etc.

The divergence between the RCT and registry studies can only be clarified by a study that 1) examines the influence of preperative factors (patient history, physical findings, radiology etc.) on outcome, and that 2) attempts a causal analysis for each reoperation. The investigators intend to do this though a cohort study including all cases of patellofemoral arthroplasty performed in Denmark from January 1, 2008 until December 31, 2015.

The purpose is to determine preoperative risk factors for revision after PFA and to provide a detailed description of indications for revision after PFA.

Study Design

Study Type:
Observational
Anticipated Enrollment :
550 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Failure Analysis of Patellofemoral Arthroplasty
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
PFA

The cohort consists of all patients operated with patellofemoral arthroplasty for isolated patellofemoral osteoarthritis in Denmark from Jan 1 2008 to Dec 31 2015. The number of patients is expected to be around 500. A patellofemoral arthroplasty is defined as an arthroplasty consisting of a metal trochlear component and a polyethylene patella component. The definition of isolated patellofemoral osteoarthritis in the study is pragmatic and given by the operating surgeon.

Procedure: Patellofemoral arthroplasty
Insertion of an artificial joint between the front of the femur and the back of the patella. The femoral component consists of a metal implant, and the patellar component is a polyethylene implant. The two components replace the original articular cartilage of the patellofemoral joint.
Other Names:
  • Artificial joint between knee cap and thigh bone
  • Outcome Measures

    Primary Outcome Measures

    1. Implant revision and reoperation rates [10-year]

      The proportion of revised and reoperated patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patellofemoral arthroplasty

    • Primary procedure performed between Jan 1 2008 and Dec 31 2015

    • Primary procedure performed in Denmark

    Exclusion Criteria:
    • Patella-nail syndrome

    • Dislocating tendon following patellectomy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Anders Odgaard
    • Stryker Orthopaedics

    Investigators

    • Principal Investigator: Anders Odgaard, MD, DMSc, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Anders Odgaard, Professor, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT04772625
    Other Study ID Numbers:
    • PFA_Failure_06
    First Posted:
    Feb 26, 2021
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Anders Odgaard, Professor, Rigshospitalet, Denmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2021